ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • Assessment and management of obstructive sleep apnoea following bariatric surgery

    Obstructive sleep apnoea (OSA) is a sleep disorder where patients stop breathing or have extremely shallow breathing during sleep. Excess weight increases the risk of OSA. However, the majority of patients with OSA that present for weight loss surgery are unaware that they have OSA. The first aim of this study is to see how common it is for patients to present for weight loss surgery with undiagnosed OSA. Before their operation, patients will answer a questionnaire (STOP-BANG) and will undergo a home sleep test (ApneaLink). Continuous positive airway pressure (CPAP) is the preferred everyday treatment for OSA. However, it is unknown whether the application of CPAP prevents complications, following weight loss surgery. The other aims of this study are to see if auto-titrated CPAP (APAP), following weight loss surgery: 1. Decreases the number of times a patient stops breathing or has extremely shallow breathing during sleep; 2. Improves oxygen levels in the blood; and 3. Prevents complications. Following their operation, patients with moderate or severe OSA (diagnosed from their ApneaLink home sleep testing) will be randomised to either: 1. Control group a. Overnight ApneaLink monitoring b. Oxygen and OSA monitoring c. Additional oxygen if required 2. APAP group a. Overnight APAP b. Oxygen and OSA monitoring c. Additional oxygen if required The number of times per hour that a patient stops breathing or has extremely shallow breathing during sleep (i.e. AHI) will be compared between the control and APAP groups. The two groups will also be compared regarding their blood oxygen levels (SpO2), additional oxygen requirement and complications, such as unplanned admissions to critical care.

  • Efficacy and cost-effectiveness of a community based model of care for older patients with complex needs: a study protocol for a multicentre randomized controlled trial using a stepped wedge cluster design

    Background: Community dwelling older persons with complex care needs may deteriorate rapidly and require hospitalisation if they receive inadequate support for their conditions in the community. This trial aims to assess the acceptability, impact and cost-effectiveness of a comprehensive, multidimensional geriatric assessment with care coordination (the OPEN ARCH intervention) in a community setting. Methods/Design: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeated cross sectional samples. General Practitioners (GPs; n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Each GP cluster will then recruit 10-12 participants. Data will be collected on each participant at three-month interval (-3, 0, 3, 6 and 9 months). The primary clinical outcomes are Emergency Department (ED) presentations, acute hospital admissions, in-patient bed days, health service (including allied health) and community support service utilization. Secondary outcomes include functional status, Quality of Life (QoL) and participants’ satisfaction. Cost effectiveness of the intervention will be assessed as a change to cost outcomes, including the cost of implementing the intervention and subsequent use of health services; and, the change to health benefits, represented by quality adjusted life years (QALYs). Discussion: The results will have direct implications for the design and wider implementation of this new model of care for community dwelling older persons with complex care needs. Additionally, it will contribute to the evidence base on acceptability, efficacy, and cost-effectiveness of the intervention for this high-risk group of older people.

  • Microbiology of the pars interarticularis in patients undergoing lumbar fusion surgery for chronic back pain and isthmic spondylolisthesis.

    This study aims to investigate whether an underlying subacute infection at the pars defect is a possible cause of pain in patients requiring lumbar spinal fusion surgery. The study will perform microbiological analysis of the bone, ligamentous, muscle and disc tissue at/adjacent to the pars defect, taken from normally discarded material intraoperatively. The presence of infection will be determined by positive bacterial culture from these sites and results analysed for statistical significance. Detection of bacteria would support an infectious rationale, as a source of back pain, in this population. This research endeavors to clarify the source of back pain in isthmic spondylolithesis patients the search for suitable, reliable and reproducible conservative treatments.

  • The Victorian Pre-Exposure Prophylaxis Demonstration Project- VicPrEP HIV prevention trial for people at risk of HIV

    VicPrEP is a demonstration project investigating the adherence, behavioural change, acceptability, safety, and feasibility of the use of HIV PrEP in the Victorian community. The nature of a demonstration study is to study patients who can feasibly be recruited. Based on Australian research undertaken by members of our study team regarding the likelihood of PrEP use in HIV negative gay or bisexual men and the likely uptake of healthy, fertile HIV serodiscordant couples we have estimated that approximately 100 patients willing to accept PrEP could feasibly be recruited into the study over a two year period. This number of patients may reasonably allow us to undertake regression analyses to determine whether a number of baseline covariables are associated with PrEP adherence, behavioural change and acceptability. However the study sample size was necessarily chosen based on feasibility of recruitment and not based upon power calculations.

  • Use of the Australian Modified Lawton’s Instrumental Activities of Daily Living Scale in the diagnosis of dementia.

    AIM The aim of this study is to investigate the ability of the Australian Modified Lawton’s IADL scale to differentiate cognitive impairment by determining ‘cut-off’ scores between Normal Cognition (NC), Mild Cognitive Impairment (MCI), and Dementia (D). HYPOTHESIS The Australian Modified Lawton’s IADL scale scores will have significant association with the diagnoses of MCI and D, hence contribute to the assessment and diagnosis of older persons presenting with cognitive decline according to standard diagnostic criteria. STUDY DESIGN This is a prospective single-blind single-centre study of patients newly referred to the Memory Clinic. METHOD The study cohort consists of older persons with no significant physical disability referred for assessment of subjective or objective cognitive decline to the Memory Service. The participants will undergo an occupational therapy (OT) clinic assessment which includes scoring the Australian Modified Lawton’s IADL scale and Timed Up and Go (TUG)assessment. The assessment will consist of a comprehensive interview of usual daily living activities and performance of several ADL based tasks. The carer is invited to be part of the interview. They will be provided with an information sheet on the research project. The occupational therapist is blinded to the diagnosis because the assessment occurs prior to any diagnosis by medical clinicians. The OT assessment is followed by medical assessment including cognitive assessment in the outpatient Memory Clinic. This will include completion of a Mini Mental State Examination (MMSE), according to the standard procedure. The final cognitive diagnosis is determined by the Geriatrician, according to DSM V criteria. The Australian Modified Lawton’s IADL scale scores are then analysed to determine the range of scores on the scale stratified by the three diagnostic groups of NC, MCI and D and to determine the between-group cut off points.

  • A study to Assess Bacterial load after a pain numbing device is applied to a blood donor's arm after routine disinfection

    A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year. We propose that a pain numbing device called “CoolSense(R)" could be effectively used by the Blood Service to reduce pain and anxiety, and enhance donor satisfaction and retention. CoolSense(R) is a hand-held non- invasive skin numbing applicator that is used to anaesthetise the skin before a painful procedure, without the use of chemicals. With an operating temperature of minus two to minus six degrees Celsius, CoolSense(R) is more effective than ice in numbing pain. In order to use CoolSense(R) in phlebotomy, the applicator must be applied to the skin after disinfection as the site would not remain desensitized for a sufficient period if applied prior to disinfection. Given that this post-disinfection application contravenes current Blood Service protocols, the objective of the bacterial load study is to assess whether the phlebotomy site remains free from microbiological contaminates after application of CoolSense(R)

  • The association between looking or smiling at a patient and requests for assistance: A single-centre, blinded, randomised, controlled clinical trial

    There is considerable anecdotal evidence that smiling at a patient while walking past their cubicle increases the number of requests for assistance. This is perceived as a nuisance by some staff who believe they are busy enough and that the assistance should be provided by the patient's attending nurse. Given this perception, some staff deliberately do not look at or smile at a patient as they walk past. This trial will determine if smiling truly does increase requests.

  • Does the use of muscle relaxants during anaesthesia for hip arthroscopies influence the pressure on the perineum?

    Many types of surgery, such as some types of hip replacement surgery, hip arthroscopies or the re-alignment of femoral fractures need to be performed on a traction table. In order to not pull the patient off the operating table when pulling on the leg, a padded perineal post is used. However, once traction is applied, the patient’s pudendal nerve region is pressurized by the post and the nerve can subsequently be damaged. This can result in significant nerve dysfunction which may be short-lived, but can also last for years after surgery. Sexual dysfunction after operations on a traction table is a long-known, but difficult to avoid problem (1-3). Mallet et al.(1) studied 168 patients after either operations on a traction table or a normal (non-traction) operating table. They found a 40.5% rate of erectile dysfunction (ED) in otherwise young, healthy males even years after operations on a traction table. Investigating potential influencing factors, the dose of the muscle relaxant administered during the anaesthetic was the only modifiable factor, with higher doses likely to prevent ED. The authors concluded that good relaxation leading to lower traction forces required and consequentially lower pressures on the pudendal nerve explained the superior outcome after deeper muscle relaxation (1). Though this theory seems logical, it has actually never been proven. Aim of this study is to determine the effect of deep muscle relaxation on the pressure on the perineum by the perineal post during operations on a traction table. Using an ultra-thin (approx.1 mm) pressure sensor foil embedded into the perineal post, we propose to measure the changes in pressures on the pudendal nerve after muscle relaxation. Fourty patients scheduled for elective hip arthroscopic surgery at Joondalup Health Campus and Glengarry Private Hospital will be included in this study. All patients will receive a standard general anaesthetic. After traction is applied on the operated leg, the resulting pressure on the perineum will be recorded. With the applied traction unchanged, the patient then receives a dose of the muscle relaxant rocuronium and the resulting change in pressure will be monitored. This concludes the study. The proposed project will close a significant gap of knowledge and, in a simple and risk-free approach, may lead to a change in anaesthesia practice. In addition, the joint width (hip) wil be measured before and after apralysis using portable xrays. If the joint width increases after the paralysis, the traction on the patients's leg will be reduced until the joint width is back to pre-paralysis status. At this stage the pressure on the pudendal nerve will be recorded again. References 1. Mallet R, et al. Urology. 2005;65(3):559-63. 2. Brumback RJ, et al. The Journal of bone and joint surgery American volume. 1992;74(10):1450-5. 3. Chan PT, et al.The Journal of trauma. 1999

  • An investigation into the immunomodulating effects of Andrographis paniculata in healthy males

    A wide range of animal and in vitro studies have demonstrated that the herbal medicine Andrographis paniculata (AP) possesses immunomodulatory, anti-inflammatory, antioxidant and anti-depressant properties. This pilot trial examining the effects of Andrographis paniculata (AP) will be carried out by researchers from the University of New England (primary investigator - Dr Linda Agnew). They have previously reported that AP induces an immune response via altered stress protein levels in ex vivo studies. A number of other human clinical trials have confirmed that supplementation with AP reduces the severity of symptoms in upper respiratory tract infections. More information is needed however, before a definitive statement can be made regardings its mode of action and efficacy as a herbal medicine. The aims of this small-scale intervention study are to examine the effects of supplementation with AP on parameters of the immune, inflammatory, stress and antioxidant responses. These aims will be achieved by measuring immune, inflammatory and antioxidant markers in blood and saliva samples as well as psychological variables collected from healthy male volunteers taking AP for two weeks at a total daily dose equivalent to 6.0 g dried leaf equivalent. All measures will be taken at commencement of the trial, prior to intervention, and after 14 days of supplementation.

  • Metabolic effects of cross-sex hormone treatment

    Biological differences between males and females are well known in terms of reproductive functioning. However, it is becoming increasingly well recognised that non-communicable chronic diseases, such as diabetes, cardiovascular disease, and many neurological and mental health disorders display sexual dimorphisms in their pathogenesis and presentation. Females are somewhat protected against both the development of insulin resistance and cardiovascular disease compared with males of a similar age. However, this difference between sexes diminishes after women reach menopause. Much of this sexual dimorphism has been attributed to the regulatory effects of the steroid sex hormones testosterone, oestrogen and progesterone. Cross-sex hormones (CSH) are a treatment option used to treat gender dysphoria (DSM V) and facilitate transition from their natal sex (i.e. sex assigned at birth) to their identified gender. Feminisation typically requires administration of androgen-blockers and co-administration of oestrogen hormones, whereas masculinisation requires administration of testosterone treatment. Treatment with CSH is usually lifelong. Evidence shows that transgender persons are at an increased risk of mental distress and chronic disease. In addition to the physical changes induced by cross-sex hormone therapy commonly associated with puberty (such as changes to body hair, skin appearance), cross-sex hormones have been shown to influence factors such as body composition. The overall effect of cross-sex hormone treatment on cardiovascular and diabetes risk is still unclear. Cross-sex hormone treatment has been reported to both improve and impair various CVD risk factors, such as fasting glucose and insulin levels, plasma docosahexaenoic acid (DHA) levels, adipokines and C-reactive protein. Studying the effect of cross-sex hormones on DHA status and other risk factors for CVD and diabetes in transgender persons undergoing hormone therapy allows a unique opportunity to investigate the contribution of sex hormones to the sexual dimorphisms apparent in both these conditions. Furthermore, investigating metabolic changes in response to cross-sex hormone treatment may help to inform dietary and/or pharmaceutical strategies for minimizing the health risks associated with receiving CSH in this at risk group. Therefore the aim of this observational study is to measure the effect of cross-sex hormone therapy on metabolic risk factors for both diabetes and CVD in transgender individuals undergoing hormone therapy.

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